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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000440-22
    Sponsor's Protocol Code Number:Version17032021
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000440-22
    A.3Full title of the trial
    Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium
    A.3.2Name or abbreviated title of the trial where available
    PREGCOVAC.BE
    A.4.1Sponsor's protocol code numberVersion17032021
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversiteit Antwerpen
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSciensano
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversiteit Antwerpen
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitsplein 1
    B.5.3.2Town/ cityWilrijk
    B.5.3.3Post code2160
    B.5.3.4CountryBelgium
    B.5.4Telephone number003232652862
    B.5.5Fax number003232652640
    B.5.6E-mailkirsten.maertens@uantwerpen.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameComirnaty
    D.3.2Product code J07BX03
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Covid-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderModerna
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCovid19 Vaccine Moderna
    D.3.2Product code J07BX03
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name COVID19 Vaccine Astrazeneca
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCovid 19 Vaccine AstraZeneca
    D.3.2Product code J07BX03
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccine responses to COVID19 vaccines administered in pregnant and
    lactating women
    E.1.1.1Medical condition in easily understood language
    Corona virus vaccine responses in pregnant and lactating women
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The one central question is whether pregnant and lactating women can
    develop similar protective immunity against COVID-19 upon vaccination,
    without safety issues. This question needs to be answered urgently and
    would help the health care workers and in a later stage the general
    population to decide whether immunization in pregnancy or in the
    postpartum period during lactation is safe and effective.
    E.2.2Secondary objectives of the trial
    In this project we will compare vaccination in pregnant women with age
    matched non-pregnant women (from the PICOVAC study, see appendix)
    and women vaccinated in the postpartum period during lactation. The
    primary objectives are to assess the immune response and safety after
    administration of COVID-19 mRNA Vaccine BNT162b2
    (Comirnaty®;Pfizer-BioNTech), or other vaccines against COVID19
    whenever available for administration in our region, in a population of
    pregnant women (N=120), age-matched non-pregnant women (120) and postpartum lactating women
    (N=100+ 120), also controlled with an existing prospective study group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female population older than 18 years.
    • Ability to provide informed consent.
    • Being vaccinated with a COVID-19 vaccine.
    • Intend to be available for follow-up visits through one year
    postvaccination.
    • Influenza and pertussis vaccination during pregnancy (as per Belgian
    recommendations) is allowed.
    E.4Principal exclusion criteria
    Serious underlying immunological condition (e.g. immunosuppressive
    disease or therapy, human immunodeficiency virus (HIV) infection…).
    • Systemic treatment with immune suppressive medication, including
    chronic steroid use of > 10 mg prednisone or equivalent.
    • Anything in the opinion of the investigator that would prevent
    volunteers from completing the study or put the volunteer at risk.
    E.5 End points
    E.5.1Primary end point(s)
    To investigate the antibody based immune response (ELISA RBD
    antibodies (IgG) ) on day 28 after the second vaccination in pregnant
    women, age matched control non-pregnant women and postpartum
    lactating women. The definition of response will be based on a
    serological correlate of protection for COVID-19 based on SARS-CoV-2
    spike(S)-protein specific serum IgG antibody levels (in IU/mL or
    seroconversion (a≥4-fold increase of the geometric mean concentration
    (GMC) of anti-S protein IgG antibodies over baseline)). For those with a
    previous COVID infection, the in house multiplex assay from Sciensano
    will be performed to discriminate between previous infection and
    vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    Secondary End Point (repeat as necessary) To investigate the safety of
    the COVID-19 vaccines described in pregnant and
    lactating women. Both immediate and long term safety data will be
    gathered in women and offspring, according to the Global Alignment of
    Immunization Safety Assessment in pregnancy (GAIA) definitions.
    Safety will be reported in terms of incidence and severity of systemic
    adverse events (AEs) during a continuous reporting system. Incidence
    and nature of newly occurring immune related AEs of grade≥3 according
    to the Common Terminology Criteria for Adverse Events version 5.0
    including information on vaccine specific safety.
    • To study the duration of the immune response using serology assays
    performed on day 7 and 28 after the second dose as well as at 6 months
    after the first dose. ELISA RBD antibodies (IgG) will be tested 7 days
    after booster dose and the titer of neutralizing antibodies 7 and 28 days
    after booster dose;
    • To investigate the efficacy of the immune response. This will be
    measured by the COVID-19 infection rate based on information collected
    through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2
    infection within a time-frame of 12 months after the start of the study.
    • In depth assessment of the immune response: By measuring the
    SARS-Cov2 specific T and B cell response and its evolution and longevity
    by sampling blood at different timepoint. B-cell immunity and T-cell
    immunity will be measured seven days and 28 days after boost
    • To assess the influence of COVID-19 vaccination on breast milk
    composition in view of protective antibodies, in women who are
    vaccinated in pregnancy and during the postpartum period.
    To assess the amount of transported antibodies to spike protein S in the
    offspring. Cord blood will be taken to measure the IgG transport.
    E.5.2.1Timepoint(s) of evaluation of this end point
    365 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no intervention
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 420
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-02-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is no specific post trial treatment foreseen. If necessary, the trial could be amended with a long term follow up period of the population for saftey reasons.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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